Updated Clinical Trial Results and Approval Progress for MS Ocrelizumab Treatment

Ocrelizumab (Ocrevus) has been FDA approved for the treatment of primary progressive multiple sclerosis (MS), and recent clinical trials with the anti-CD20 monoclonal antibody have revealed significant decreases in disease activity and disability progression in relapsing MS.

The results of the trials, presented at the American Academy of Neurology (AAN) Meeting, showed that 4 years of continuous treatment with Ocrevus resulted in a sustained disease activity. In addition, there was delayed cognitive decline and improved cognitive function in relapsing MS. Ocrevus also reduced the presence of nerve damage and inflammation biomarkers in people with relapsing MS.

“The OCREVUS data shared at AAN show the impact of this targeted B-cell therapy on slowing disability progression in MS, and further support the approach of early treatment. In the extension studies, patients who received OCREVUS continuously experienced less disease progression than those who began treatment at a later time point,” said Stephen Hauser, MD, chair of the Scientific Steering Committee of the OPERA studies, director of the Weill Institute for Neurosciences and chair of the Department of Neurology at the University of California, San Francisco in a statement.

Another takeaway from the trials included new safety data that remained consistent with the favorable benefit-risk profile of Ocrevus in relapsing and primary progressive MS.

“These data, which show that OCREVUS not only delayed onset of documented cognitive decline, but may also improve cognitive function in people with multiple sclerosis, support a potential role for this therapy in addressing one of the most important, common and challenging realities of multiple sclerosis-induced disability,” stated Stanley Cohan, MD, PhD, medical director of Providence Multiple Sclerosis Center, Portland, Oregon.

While the FDA has approved Ocrevus and researchers continue studying the drug’s efficacy, the National Institute for Health and Care Excellence has been working to produce guidance on using ocrelizumab in the National Institutes of Health (NHS) in England.

The recommendations for the guidance were made by the appraisal committee which considered the evidence submitted by the company and the views of non-company consultees, commentators, and patient and clinical experts. The recommendations that will be considered by the consultees include:

• Ocrelizumab is not recommended, within its marketing authorization, for treating relapsing forms of multiple sclerosis in adults with active disease defined by clinical or imaging features.
• This recommendation is not intended to affect treatment with ocrelizumab that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.

The committee noted these recommendations are a result of the uncertain evidence whether ocrelizumab slows disease progression compared with other treatments.